deferasirox

What is the most important information I should know about deferasirox?

You should not use this medication if you are allergic to it, or if you have severe kidney disease, advanced cancer, a blood cell disorder, or if you are also using theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl).

Before taking deferasirox, tell your doctor if you have kidney or liver disease, cancer (especially blood cell cancer such as leukemia), a history of stomach or intestinal bleeding, vision or hearing problems, or a weak immune system.

Take deferasirox on an empty stomach, at least 30 minutes before you eat.

Do not chew, crush, or swallow the tablet whole. Place the tablet into a glass of apple juice, orange juice, or water and allow the tablet to disperse in the liquid. Drink this mixture right away.

Stop using this medication and call your doctor at once if you have a serious side effect such as swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all, upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes), bloody or tarry stools, coughing up blood, increased thirst and urination, problems with vision or hearing, fever, chills, flu symptoms, mouth sores, easy bruising or bleeding, or a severe blistering skin rash.

While you are taking deferasirox, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

There are many other medicines that can interact with deferasirox. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

What is deferasirox?

Deferasirox binds to iron and removes it from the blood stream.

Deferasirox is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.

Deferasirox may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using deferasirox?

You should not use this medication if you are allergic to it, or if you have:

• severe kidney disease;
• advanced cancer;
• a blood cell disorder such as anemia (lack of red blood cells) or low levels of platelets in your blood; or
• if you are also using theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl).

To make sure you can safely use deferasirox, tell your doctor if you have any of these other conditions:

• kidney disease;
• liver disease;
• cancer (especially blood cell cancer such as leukemia);
• a history of stomach or intestinal bleeding;
• vision or hearing problems; or
• a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving steroids, chemotherapy, or radiation.

FDA pregnancy category C. It is not known whether deferasirox will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether deferasirox passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking deferasirox.

Serious side effects may be more likely in older adults taking deferasirox.

How should I take deferasirox?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Take deferasirox on an empty stomach at least 30 minutes before eating. Take the medication at the same time every day.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. Drink plenty of fluids while taking deferasirox to keep from getting dehydrated.

Do not chew, crush, or swallow the deferasirox tablet whole. Place it into a glass of apple juice, orange juice, or water and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

If you take less than 1000 milligrams (1 gram) daily, dissolve the deferasirox tablets in about one-half cup of apple juice, orange juice, or water. If you take more than 1000 milligrams daily, dissolve the tablets in about 1 cup of apple juice, orange juice, or water.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

Store at room temperature, away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking deferasirox?

While you are taking deferasirox, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Do not use other iron chelating medicines such as deferoxamine (Desferal), unless your doctor has told you to.

Deferasirox may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What are the possible side effects of deferasirox?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using deferasirox and call your doctor at once if you have a serious side effect such as:

• kidney problems - drowsiness, confusion, mood changes, swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all;
• liver problems - nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• increased thirst and urination, loss of appetite, weakness, constipation;
• problems with vision or hearing;
• fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
• severe blistering, peeling, and red skin rash.

Less serious side effects may include:

• mild nausea, stomach pain, diarrhea, vomiting;
• dizziness, anxiety, tired feeling;
• sleep problems (insomnia);
• mild rash, discolored skin; or
• headache, cough, sinus pain, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect deferasirox?

Many drugs can interact with deferasirox. Below is just a partial list. Tell your doctor if you are using:

• alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or zoledronic acid (Reclast, Zometa);
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifampin (Rifater, Rifadin, Rifamate), telithromycin (Ketek), and others;
• birth control pills;
• a blood thinner such as warfarin (Coumadin, Jantoven);
• cancer medication such as paclitaxel (Taxol) or tamoxifen (Soltamox);
• cholesterol-lowering drugs such as cholestyramine (Prevalite, Questran), atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin);
• heart or blood pressure medications such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc, Lotrel), carvedilol (Coreg), diltiazem (Cartia, Cardizem), felodipine (Plendil), losartan (Hyzaar, Cozaar), nifedipine (Adalat), nisoldipine (Sular), torsemide (Demadex), or verapamil (Calan, Covera, Isoptin);
• heart rhythm medication such as quinidine (Quin-G);
• HIV medicines such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), saquinavir (Invirase), and others;
• medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune) or tacrolimus (Prograf);
• montelukast (Singulair) or zafirlukast (Accolate);
• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others;
• a sedative such as alprazolam (Xanax), diazepam (Valium), midazolam (Versed), or triazolam (Halcion);
• seizure medications such as fosphenytoin (Cerebyx) or phenytoin (Dilantin);
• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others;
• sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or
• type 2 diabetes medications such as glimepiride (Amaryl), glipizide (Glucotrol), nateglinide (Starlix), pioglitazone (Actos, Actoplus Met), repaglinide (Prandin), rosiglitazone (Avandia, Avandamet), or tolbutamide (Orinase).

This list is not complete and there are many other medicines that can interact with deferasirox. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about deferasirox.